FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1853588
·
Received October 5, 2010
Report
- Report Number
- 2124215-2010-14926
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 19, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD REMAINS IMPLANTED. AS A RESULT, BOSTON SCIENTIFIC CRM IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHEST PAIN. UPON CHECKING THE SYSTEM, THERE WAS NO CAPTURE IN THE RIGHT VENTRICLE AND IMPEDANCE MEASUREMENTS VARIED. A CHEST X-RAY REVEALED THAT THE LEAD HAD PERFORATED AND WAS LOCATED IN THE PERICARDIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Life Threatening | 4469| 4470| S606 |